The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) of pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

Have stage I or II primary lung cancer and who are felt not to be candidates for resection based upon co-morbid disease or who refuse lung resection.

Have metastatic tumors to the lung, and who meet criteria for metastasectomy but who are felt not to be candidates for resection of all metastases. All metastases should be treatable by RFA alone or in combination with resection.

Have positive tissue diagnosis by previous resection (less than 6 months) or by radiologic biopsy.

Have clinically suspicious disease defined as a new lesion on chest CT or a suspicious PET scan.

Have RF ablation target lesions of 4 centimeters or less in diameter.

Exclusion Criteria:

If the lesion is centrally located, less than 3 centimeters from the hilum.

If the target lesion is greater than 4 centimeters in diameter.

If the lesion is metastatic and the primary site is not controlled.

If extra-thoracic metastatic disease is present.

If there are more than 3 tumors in one lung.

If there are greater than 6 metastatic tumors in total (bilateral).

If it is felt that all metastases cannot be treated by RFA alone or in combination with resection.

If the patient is pregnant or nursing at the time of the procedure.

If the patient has malignant pleural effusion.

If the patient is unwilling or unable to provide consent for the procedure.

If the patient is less than 18 years of age (the short form [SF]-36 is not designed for patients less than 18 years of age).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280189